NCT06814067View on ClinicalTrials.gov

Phase II Multi-centered Study of Perioperative Ivonescimab Versus Pembrolizumab Combined with Standard of Care (SOC) in Patients with Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

February 10, 2025

Primary Completion Date

February 10, 2029

Study Completion Date

March 1, 2030

Conditions
Head and Neck Squamous Cell CarcinomaHead and Neck Squamous Cell Carcinoma HNSCC
Interventions
DRUG

Pembrolizumab

Two cycles of neoadjuvant pembrolizumab (200mg q3w) followed by radical surgery. Adjuvant radiotherapy/chemoradiotherapy is decided based on pathological risk factors. Fifteen cycles of pembrolizumab (200mg q3w)maintenance therapy was given.

DRUG

Ivonescimab

Two cycles of neoadjuvant Ivonescimab (10mg/kg q3w) followed by radical surgery. Adjuvant radiotherapy/chemoradiotherapy is decided based on pathological risk factors. Fifteen cycles of Ivonescimab maintenance therapy (10mg/kg q3w) was given.

PROCEDURE

Surgery

Radical surgery

RADIATION

Adjuvant radiotherapy

Adjuvant radiotherapy with/without concurrent cisplatin-based chemotherapy, based on pathologic risk factors.

Trial Locations (1)

200032

Fudan University Shanghai Cancer Center, Shanghai

All Listed Sponsors
collaborator

Fujian Cancer Hospital

OTHER_GOV

lead

Fudan University

OTHER